Device for storing and dispensing flowable compositions

ABSTRACT

The invention relates to a device for storing and dispensing a flowable composition. Said device comprises a first ( 1 ) and a second film ( 2 ), a dispensing zone ( 4 ), a first chamber ( 5 ), containing a first substance (A) and a second chamber ( 6 ), containing a second substance (B). Said chambers are interconnected by a transition zone ( 3 ) that can be selectively opened. At least one of the films is deep-drawn in the region of the chambers and at least one of the films is pre-formed in the region of the second chamber, in such a way that once the device has been activated by opening the transition zone, the first substance can to a great extent be completely transferred to a second chamber, increasing the volume of said chamber as a result.

BACKGROUND AND SUMMARY OF THE INVENTION

The invention relates to a device for storing and dispensing acomposition of least two components which is capable of flowing aftermixing.

Small amounts of liquid can be stored and dispensed in receptacles inthe form of blister packs. In the thermoformed part of the pack closedoff by a removable film there are formed, for example, two recesseswhich are separate from each other. The first recess may contain a smallamount of liquid, and a brush may be placed in the other recess.

International Patent Document WO-96/03326 describes, for example, adisposable receptacle which has depressions for storing a medicament andan applicator. Both depressions are protected from contamination bymeans of a peelable covering film. In one embodiment, by pressing on thedepression containing the medicament, said medicament is transferredinto the depression containing the applicator in order to wet theapplicator. It is explained that this is possible only when the coveringfilm is not bonded to the receptacle in the transition zone between thetwo depressions.

U.S. Pat. No. 3,835,834 discloses a treatment kit which has twodepressions in a main body, which contain a care substance on the onehand and a swab on the other hand. The main body containing the caresubstance and the swab is protected from contamination by means of asealing film.

European Patent Document EP 0 895 943 A discloses a device for storingand dispensing a flowable substance, with a container made up of twofilms which are connected to each other to form two chambers forreceiving substances and a pocket which is separate from the chambersand is used for removing the mixture of the two substances. Theseparation between one chamber and the pocket has a transition zone thatcan be selectively opened. For activating the device, first pressure isexerted on one chamber, whereby the substance located in it istransferred into the second chamber via the transition zone. As aresult, a positive pressure builds up in the second chamber and leads tobulging of one of the films forming the chambers. To prevent the mixturefrom flowing back into the first chamber, it is necessary for the deviceto be bent in the zone between the two chambers. This does not eliminatethe possibility of operator errors.

It is consequently a disadvantage of the devices known from the priorart that they are only suitable with reservations for dispensinghomogeneous compositions which can be obtained by mixing two substancesstored separately in the device. In particular, in the case ofcompositions with different volumes or states of aggregation of theirindividual constituents, a homogeneous and reproducible mixing resultoften cannot be ensured.

The prime object of the present invention is to provide an improveddevice for storing and dispensing mixtures.

A further object can be regarded as that of providing a device whichmakes it possible for even relatively large amounts of substance to bestored and dispensed without impairing the mixing result.

A further object can be regarded as that of providing a multi-chamberdevice which to a great extent prevents the mixture to be dispensed fromflowing back into one of the chambers of the device during dispensing.

These objects are achieved by providing a device such as that describedin the claims.

The terms “comprise” or “include” introduce a list of features which isnot considered to be exhaustive. The fact that the word “a” is used inthe claims before stating a feature does not exclude the possibilitythat the features stated may be present as a plurality, in the sense of“at least one”.

The device makes it possible to store, mix and dispense flowablecompositions of which the individual constituents can be storedseparately from one another in the device before mixing. The device isactivated by pressure being exerted on the first chamber, whereby thesubstance located in this chamber is transferred into the second chambervia the transition zone that can be selectively opened. The transitionzone that can be selectively opened consequently represents, as it were,a kind of predetermined breaking point.

The mixing of the two substances takes place in the second chamber, inwhich the second substance is located.

If, by reason of its volume, the second chamber cannot receive the firstsubstance, or only under more difficult conditions, as in the deviceaccording to European Patent Document EP 0 895 943 A, only part of thefirst substance can be mixed with the second substance. This isdisadvantageous, since a reproducible mixing result is required, inparticular in the medical sector. Mixtures with deviations in theconcentration of individual constituents are in many cases unusable.

The present invention solves this problem, since, according to theinvention, the second chamber is designed in such a way that it canreceive not only a first substance but also a second substance, it beingpossible for the two substances to be mixed in the device without thedevice having to be opened beforehand, but opening being possiblewithout any problem after mixing.

This is ensured by the volume of the second chamber constantly allowingitself to increase.

For this purpose, the at least one of the films forming the chambers ofthe device is pre-formed or plastically deformable in the zone of thesecond chamber.

The device according to the invention also makes it possible to followthe activation of the device by exerting pressure on the first chamber,in particular visually. The transfer of the first substance from thefirst chamber into the second chamber brings about a permanent increasein volume of the second chamber, which can be detected from outsideduring use.

The term “pre-formed” in the sense of the invention is to be understoodas meaning a plastic, defined deforming or pre-forming of a film, itbeing possible for the film to be converted from this form into anotherform in a controlled and deliberate manner. This includes pre-formingboth by peelable sealing with another film and seal-free zones.Pre-forming can be achieved, for example, by thermoforming a film bymeans of thermoforming molds.

Films in the sense of the invention are deformable, in particularplastically deformable, if, when they are exposed to an external force(for example by an internal pressure building up in a chamber when thedevice is activated), they yield to this force while deforming, forexample by permanent expansion. Suitable films which can be deformed bythe activation of the device preferably do not have any appreciableelasticity and consequently have no appreciable recovery.

A film is expandable in the sense of the invention if it can bepermanently expanded or deformed by the internal pressure building upwhen the device is activated.

Since the volume of the second chamber increases only “when required” byactivation of the device, the invention makes possible a minimal packvolume for the substances to be stored and to be mixed.

Furthermore, the substances can be filled into the chambers of thedevice with virtually no inclusion of atmospheric oxygen or other gasesin the dead volume, since the additional volume required in the secondchamber for mixing is automatically provided when the first substance istransferred from the first chamber into the second chamber.

The creation of a compressed gas cushion (air spring) in the secondchamber by the transfer of the first substance from the first chamberinto the second chamber, which would force one of the substances backinto the first chamber, is consequently prevented to the greatestextent.

A similar effect can be achieved—albeit with high technicalexpenditure—by filling the device under vacuum. In this case, the volumenot filled by the substance (dead volume) during filling is replaced bya vacuum, which after sealing of the device and subsequent exposure ofthe device to atmospheric pressure leads to corresponding shrinkage ofthe zones of the volume that are under vacuum. By combining the twopossibilities, the dead volume can be reduced virtually completely.

The device is suitable, in particular, for storing, mixing anddispensing substances which are present in the device in differentvolumes.

To ensure that the substance with the smaller volume takes partsubstantially completely in the mixing operation and that instances ofmisapportionment are prevented during mixing, it is expedient to storethis substance in the second chamber and to carry out the mixing in thischamber. The substance with the greater volume is in this respectexpediently stored in the first chamber. In this way, a reproduciblemixing result that is virtually independent of the user is ensured whenthe substance with the greater volume is transferred from the firstchamber into the second chamber.

By bending the device in the zone between the chambers, the transitionzone or zones that can be selectively opened can be closed again whenrequired. Flowing back of the mixed substances into the other chamber isthen virtually impossible, so that the mixed substances can betransferred into the dispensing zone by pressure being applied to theouter zone of the films forming the second chamber.

The volume of the first chamber usually lies in the range from 0.01 to100 ml, preferably in the range from 0.05 to 50 ml.

The volume of the second chamber is preferably less than or equal to thevolume of the first chamber, at least before the activation of thedevice, and lies in the range from 0.001 to 100 ml, preferably in therange from 0.01 to 25 ml.

A chamber has, for example, a diameter from 1 to 100 mm, preferably inthe range from 5 to 50 mm. The total volume which can be applied usuallylies in the range from 0.011 to 200 ml, preferably the range from 0.06to 75 ml.

To achieve the increase in volume of the second chamber essential forthe invention, different embodiments are conceivable.

The increase in volume can be achieved, for example, by a substantiallyconcave formation of the base film and substantially convex formation ofthe covering film (from the view of the product filled into thechamber). The covering film is for this purpose likewise thermoformedsomewhat in the area of the second chamber and connected to the secondfilm in such a way that the thermoformed zone can bulge outward when thedevice is activated.

To reduce the resistance with which the thermoformed film opposes thepressure building up in the chamber when it is bulging outward, and toensure a maximum increase in volume, the following method of productionhas proven to be advantageous:

The covering film is firstly thermoformed and subsequently inverted, sothat the indentation in the film is located on the side opposite fromthe thermoformed mold. The material displacement occurring in the filmduring thermoforming, and the associated stress, are at least partlyretained during the inversion, so that the film is, as it were, in aquasi prestressed state and can consequently be inverted outward moreeasily upon activation. The covering film produced in this way isfinally sealed onto the likewise thermoformed base film. The invertedindentation in the covering film and the indentation in the base film inthis case point in the same direction and form between them the volumeof the second chamber in the storing state.

The description of the form of a film as “concave” or “convex” does not,however, exclude the possibility of the film changing its curvaturecharacteristics, in particular in edge zones.

It is also conceivable to thermoform only the base film, to be precisein a form which makes it possible for the film to bulge when the deviceis activated. Such a form can be achieved for example by the initiallyconvexly outward-bulged base film being at least partially pressed inagain. This form can, however, also be achieved in a single step byproviding a corresponding mold. Consequently, a film which is deformedin a more or less wave-shaped manner in cross section is obtained.

In a variant of this embodiment, the base film has, viewed in crosssection, a number of wave peaks and wave valleys, it being possible forthe film to be sealed with the covering film in a peelable manner in thearea of a wave valley, so that the chamber is subdivided into a numberof compartments.

The device is consequently suitable, if appropriate, for storing andmixing more than two substances. The second substance, expedientlysealed in a peelable manner in the center of the second chamber, isinitially surrounded without direct contact, in a channel-like manner,by the first substance transferred from the first chamber into thesecond chamber when the device is activated. With increasing pressure onthe first chamber and transfer of an increasing amount of secondsubstance, the sealing seam in the area of the wave valley begins tocome apart, whereby the first substance begins to wet the secondsubstance.

A further possibility is for the second chamber to be sealed in apeelable manner in an edge zone or the two films forming the chamber tobe pressed one onto the other, lying flat, in this zone without sealingthem in a peelable manner in this zone. This edge zone is adjoined by anon-peelable sealing zone, which in the end, and in particular, when thedevice is activated, seals off the chamber from the outside. Thisnon-peelable (firmly sealed) sealing zone is only interrupted by apeelable transition zone at the point at which the second chamber opensinto the dispensing zone and the connection between the first chamberand the second chamber is to be established. The increase in volume ofthe second chamber when the device is activated takes place by thecovering film allowing itself to be detached or lifting off from thebase film in this area.

It has been found that peelably sealed or unsealed edge zones may have astronger recovering tendency after the increase in volume brought aboutby activating the device than films which are converted from a convexform into a concave form upon activation.

An increase in volume of the second chamber can also be achieved, forexample, by at least one of the films forming the second chamber beingdeformable or expandable, in particular, plastically deformable. Whenthe first substance is transferred into the second chamber, in this casethe increase in volume takes place by the plastically deformable filmallowing itself to expand, preferably without appreciable recovery.

The possibilities stated above can of course also be combined with oneanother.

The width of the peelably sealed edge zone can in principle be any widthdesired and depends on the desired increase in volume. A width in therange from 0.1 to 40 mm, preferably from 0.5 to 20 mm, has provensuccessful.

The zones that can be selectively opened, or the peelably sealed zones,preferably open when a hydrostatic pressure in the range from 3 to 300N/cm², particularly preferably in the range from 15 to 150 N/cm², isexerted by a flowable substance on this zone. The pressure to be appliedfor opening the zones that can be selectively opened may vary for eachzone that can be selectively opened, depending on the embodiment. Thismakes possible a directed transfer of the substances to be mixed intothe respective chambers as far as the dispensing zone.

Depending on the embodiment and films used, slight changes in geometryof the device may occur, in particular, in the area of the secondchamber, when the device is activated. If appropriate, one of the filmsforming the chamber bulges slightly outward as the pressure increasinglybuilds up.

Preferably, the second chamber is also connected to the dispensing zonevia a transition zone that can be selectively opened. This makes easierhandling possible. The mixed composition can in this case be dispensedby exerting pressure on the second chamber, without further auxiliarymeans being necessary for opening the device. Expediently, when theflowable composition is being dispensed, the transition zone to thefirst chamber is closed by bending it over.

Dispensing zone in the sense of the invention is to be understood hereas meaning the zone of the device via which emptying of the mixedcomposition takes place.

The dispensing zone is preferably shaped in such a way that dependable,uniform dispensing can be ensured.

In this respect, the introduction of flow barriers, as described in DE19 962 436 A, has proven successful. Barriers of this type ensure thatthe composition is not spattered when it is dispensed.

By including flow barriers in the dispensing zone, the substance isinfluenced when it flows out through the dispensing zone in such a waythat slow delivery from the dispensing zone is ensured at the mouth ofthe latter. Consequently, spattering of the substance caused by exertinghigh pressure on the second chamber when the transition zone suddenlyopens is also prevented. The increase in the flow resistance, andconsequently the hindering of the outflow of the substance, can beachieved by extending the flow path around the barriers, if appropriatewith a change of direction, or by reducing the flow cross section bysealing points or sealing webs arranged in an offset manner.

Furthermore, an increase in the flow resistance can be achieved by astraight constriction of the flow cross section in the dispensing zone.In this case, a restriction by a factor of 1.5 to 5, preferably by afactor of 2, is envisaged. A device of this type is suitable, inparticular, whenever low-viscosity substances are to be dispensedwithout further auxiliary means in a targeted, easy manner withoutspilling.

Furthermore, the device may have a dispensing zone which isgeometrically arranged in such a way in relation to the transition zonethat the longitudinal axis of the dispensing zone does not run throughthe transition zone. In this case, the dispensing zone may have anenlarged volume, in particular, in the part adjoining the transitionzone. It is particularly preferred if the dispensing zone is formed as apocket. In the case of this arrangement, it is advantageous that thesubstance is conveyed into the dispensing zone by pressure on thesubstance located in the chamber when the transition zone suddenlyopens. In said dispensing zone, the substance experiences a change indirection of the outflow direction as a result of the arrangement of thelongitudinal axis of the dispensing zone which does not intersect thetransition zone. On account of this change in direction, a slow deliveryfrom the dispensing zone is ensured at the mouth of the latter. If thedispensing zone is formed as a pocket, the substance suddenly flowingout is initially collected in this pocket. Then slow and directeddispensing is possible from this pocket.

To prevent the substances located in the second chamber after theactivation of the device from flowing back into the first chamber, itmay also be advantageous to fit a valve in the transition zone betweenthe two chambers.

A suitable valve is represented for example by a flexible film (referredto hereafter as valve film), which is fastened in the transition zonebetween the two chambers, for example to the base film, and protrudesinto the second chamber. The first substance can, as already described,be transferred from the first chamber into the second chamber. As soonas the first substance has been transferred completely into the secondchamber through the now opened transition zone, the valve film preventsflowing back of the substances located in the second chamber, in that itblocks the transition zone.

Among the advantages provided by this embodiment is that the device doesnot need to be bent in the transition zone between the two chambersafter activation to exclude the possibility of substance flowing backinto the first chamber. In the case of this embodiment, it is also notnecessary for the films forming the second chamber to be plasticallydeformable.

For production reasons, it may be advantageous if the valve filmadditionally lines the first chamber completely or partly and, ifappropriate, reaches into the firmly sealed edge zone of the firstchamber. In this case, it may be adequate if the valve film adheres onits upper side to the base film only in the transition zone.

The transition zone that can be selectively opened, in combination withthe valve film can, for example, also be realized in the following way:the valve film is, for example, connected to the covering film in thearea of the first and second chambers and in the transition zone. In thearea of the first chamber, in the vicinity of the transition zone thatcan be selectively opened to the second chamber, the valve film has anopening which has, for example, been punched out from the valve film.The valve film has, furthermore, in the zone of the second chamber a tabor tongue, which can be formed, for example, by punching or cutting outa corresponding shape from the valve film. The residual zone of thevalve film detached in the zone of the tab is in this case not removed,but remains in the zone of the second chamber. The valve film is sealedin a peelable manner with the covering film, preferably only in thetransition zone.

When the device is activated, the substance is transferred from thefirst chamber into the second chamber through the opening in the valvefilm via the transition zone that can be selectively opened, with thetab of the valve film lifting up. As soon as substantially the entireamount of the first substance has been transferred into the secondchamber, the tab is pressed against the covering film in the area of thesecond chamber, or into the existing punched clearance, by the internalpressure building up in the second chamber and pressure relief of thefirst chamber, and in this way prevents the flowing back of thesubstance into the first chamber.

In a further embodiment, a third chamber, which is filled with a thirdsubstance, may be located in the transition zone that can be selectivelyopened, between the first chamber and the second chamber. When thedevice is activated, in this case firstly the third chamber is openedand the first substance emerging from the first chamber is united withthe third substance, located in the third chamber, before it finallyenters the second chamber, in which the actual mixing operation takesplace.

This arrangement is suitable in particular for intensive mixing ofidentical or different liquids, which are located in the first andsecond chambers, with for example a powder, which is located in thethird chamber lying in between. The third chamber can be flushed throughparticularly intensively by repeated, alternating exertion of pressureon the first chamber or second chamber and the substances locatedtherein. In this case, a volume reservoir located in the first and/orsecond chamber is advantageous.

The device is usually a disposable pack (unit dose). The device issuitable for storing and dispensing all substances for whichreproducible mixing and apportioning, to a great extent independently ofthe user, is required.

In particular, the device has proven successful in the area of human andveterinary medicine and in the dental sector.

Substances to be stored are usually liquids, pastes and/or solids. Thesolids may in this case be in the form of powder, tablets or granules.

The device is preferably suitable for storing, mixing and dispensingcompositions chosen from: human and veterinary medicaments, woundcleaning agents, dental products, adhesives, impression materials,paints, in particular, two-pack paints, foods to be stored separately ortheir constituents.

The device substantially comprises a first base or lower film and asecond covering or upper film, which for their part may be formed asmultilayer films.

Depending on the embodiment which is chosen to make possible theincrease in volume essential for the invention, at least one of thefilms is plastically deformable, preferably thermoformable whiledeforming.

Preferably used as films are those which have adequate diffusionimpermeability.

Depending on the nature of the substance to be stored, the films shouldalso be resistant to aggressive substances, for example causticsubstances and/or substances having the properties of solvents.

Depending on the application area and the desired deformability, thefilms are stretched or are in an unstretched state before the activationof the device.

The film constituents may be chosen from plastic films, metal foils andceramic sheets.

Conceivable as plastic films are, for example: PE, PP, PTFE, PET, PA,PBT, PVC, EVA, PVF (polyvinyl fluoride).

Conceivable as metal foils are, for example: Al, Sn, Au, Ag, Fe, Pb.

Ceramic sheets are to be understood as meaning films which have, forexample, a layer containing SiOx.

The film may, in principle, be of any desired construction and is based,inter alia, on the nature of the substances to be stored.

A film construction with the sequence from the outside inward of PET,Al, PET, PE or PP, Al, PET, PE, if appropriate also without a PET filmas a middle film, has proven to be advantageous.

With the exception of the zones forming the chambers, the films arepreferably connected to one another in surface-area contact.

The connection of the first film to the second film may take place, forexample, by hot-sealing, cold-sealing, adhesive bonding and/orultrasonic welding with sonotrodes.

A multilayer construction of the first and second films can be achievedby laminating, calendering, laminating of various layers comprisingsingle films, if appropriate also by vapor-depositing, for example withmetals.

To ensure that the substances, which are introduced into the device andcan be applied, are protected from incident light, for example, thefilms are preferably configured in such a way that, in an areasurrounding the chamber, they are connected to one another by twospaced-apart sealing seams.

The device can in principle be of any desired form, but is preferablyadapted to the nature of the substances stored.

The chambers are preferably formed such that they are round (circular oroval) but, if appropriate, also angular (square, rectangular ortriangular).

The transition zone is designed such that, in the storing state, itforms a sealed closure, both between the two chambers and with respectto the zone via which the composition is to be dispensed.

The transition zone that can be selectively opened, or the predeterminedbreaking point, can be achieved for example by cold-sealing,hot-sealing, ultrasonic welding or adhesive bonding, a different energyinput, preferably lower energy input, taking place in the case ofhot-sealing in comparison with the other sealing zones. This can becontrolled by means of temperature, pressure and/or holding time.

Another possibility is to introduce adhesion-reducing foreign particles,such as punched pieces of peeling film or spots of hot-melt adhesive,between the first film and the second film in the area of thepredetermined breaking point. In this case, firmly sealing films arepreferably used as the upper and lower films.

The dispensing zone is preferably formed such that it is open toward oneside, i.e. in pocket-like, and if appropriate formed such that adispensing instrument or an applicator can even be introduced in thestoring state. The dispensing zone may also serve as an applicationdevice itself if there is a correspondingly small diameter of theopening toward the outside, for example in the form of a cannula.

The separation between the chamber or chambers and the dispensing zoneis configured with respect to the distance and also with respect to thestrength of the adhesive bond such that there is a further predeterminedbreaking point.

The possibly present application instrument is preferably designed likea brush or a swab. An application instrument with a spherical tipbearing bristles or brush hairs has proven to be favorable. Furthermore,pipettes, cotton sticks, sponges, spatulas or spray heads sealed intothe dispensing zone may also be used as an application instrument or asapplication devices.

Furthermore, it is favorable when using an application instrument if thedispensing zone is to a great extent sealed off from the outside by theapplication instrument.

A dispensing instrument located in the dispensing zone or onlyintroduced into it at this or a later point in time is wetted when thedevice is activated and can subsequently be used for applying thereleased substance.

It is also conceivable for the application instrument to be moved in thedirection of the second chamber, in order to release the transition zonethat can be selectively opened. This likewise results in the dispensinginstrument being wetted.

If repeated application of the released substance is necessary, theapplication instrument can be re-inserted into the pocket.

The dispensing zone or the application instrument is preferably designedin such a way that, when it is re-inserted, wetting of the outer portionof the application instrument does not take place.

This may happen, for example, by a channel-shaped formation of thedispensing zone and a matching formation of the application instrument.

It is also conceivable for one of the films to be designed in adish-shaped or well-shaped manner in the dispensing zone, into which thesubstance is conveyed for repeated wetting of the application instrumentwithout wetting the shaft by squeezing out the chamber in a way similarto in the case of tubes.

The device can be produced, for example, by the following method:

-   -   a) provision of a first film,    -   b) partial thermoforming of the first film, thereby forming two        chambers,    -   c) filling of the two chambers with two substances to be mixed,    -   d) application of a second film,    -   e) connecting of the second film to the first film to a great        extent in surface-area contact, leaving the chambers free and        forming a transition zone that can be selectively opened between        the two chambers and in the dispensing zone.

Depending on which embodiment is chosen for the increase in volume ofthe second chamber, further steps are to be applied.

The first film maybe sealed with the second film only in a peelablemanner in the edge zone of the second chamber.

Alternatively, the second film is thermoformed in the area of the secondchamber before application (step d)) and subsequently applied with thecurvature in the direction of the thermoformed area of the first filmfrom step b) and sealed, with a concave-convex chamber being formed.

Exemplary embodiments of the invention are explained in more detailbelow on the basis of the drawings. The representations in dashed linesshow the device after activation.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows one possible embodiment of the device in cross section,

FIG. 2 shows a further embodiment of the device in cross section,

FIG. 3 shows a third possible embodiment of the device in cross section,

FIG. 4 shows the embodiment according to FIG. 1 in plan view, and

FIG. 5 shows one possible embodiment of the device, including a valve,in cross section.

DETAILED DESCRIPTION OF THE DRAWINGS

The device according to FIG. 1 has a base film (1) and a covering film(2). In the area (3), the two films are sealed to each other in apeelable manner, whereby a transition zone that can be selectivelyopened is formed between the two chambers (5) and (6). In FIG. 1, thedispensing zone (4) also has a transition zone that can be selectivelyopened. In the chambers (5) and (6) there are two substances (A) and (B)to be mixed. The volume of the second chamber (6) can be enlarged assoon as the device is activated by exerting external pressure on thefirst chamber (5). In this respect, the base film (1) is curvedconcavely outward in the zone of the second chamber (6) and the coveringfilm (2) is curved or pre-formed convexly inward.

After activation, the substance (A) from the first chamber (5) islocated together with the substance (B) in the second chamber (6). Then,like the base film (1), the covering film (2) likewise has a concavelyoutward-curved form (dashed line in FIG. 1).

FIG. 2 shows a further possible embodiment for the device in crosssection. The increase in volume of the second chamber (5) can beachieved by pre-forming of the base film (1) in the zone of the secondchamber (6) with wave peaks (9) and wave valleys (10). Depending on theembodiment, the base film 1 may be sealed in a peelable manner to thecovering film (2) not only in the transition zone (3) but additionallyat least in the zone of a wave valley (10).

After activation, both substances (A) and (B) are located in the secondchamber (6), the volume of which has been increased by bulging of thewave valley (10) into a form which, overall, is to a great extentconcave (dashed line in FIG. 2).

FIG. 3 shows a further possible embodiment of the device in crosssection. In the edge zone (11) of the second chamber (6), the base film(1) and the covering film (2) are pre-formed such that they can beseparated from each other. This pre-forming can be achieved, forexample, by peelable sealing of the films in this area or by the filmbeing pressed one onto the other, lying flat, in this area, withoutbeing sealed in a peelable manner in this area.

After activation, the base film (1) has been separated or lifted offfrom the covering film (2) in the edge zone (11) of the second chamber(6) (dashed line in FIG. 3). Both substances (A) and (B) are thenlocated in the second chamber (6). For opening the device, after bendingof the device in the transition zone (3) and subsequent exertion ofpressure on the second chamber (6), the resistance caused by thetransition zone that can be selectively opened is overcome in thedispensing zone.

FIG. 4 shows the device based on FIG. 1 in plan view. The dispensingzone (4) has flow barriers or is formed in a meandering manner in thedispensing area (13). This prevents spattering when the composition isdispensed from the device.

In FIG. 5, there is in the first chamber (5) and in the transition zone(3) that can be selectively opened a further film (12), which isfastened to the base film (1) and protrudes into the second chamber (6),the film (12) not necessarily being thermoformed in the area of thesecond chamber. This film (12) performs a valve function, which preventsthe substances (A) and (B) that are located in the second chamber (6)after activation of the device from being able to return again into thefirst chamber (5) when, to dispense the composition comprising thesubstances (A) and (B), pressure is exerted on the second chamber (6) inorder to open the transition zone that can be selectively opened to theoutside in the dispensing zone. In this embodiment, the transition zone(3) that can be selectively opened is located between the valve film(12) and the covering film (2).

The dashed representation in FIG. 5 shows the device after activation.The covering film (2) has bulged outward as a result of the built-upinternal pressure in the second chamber (6). This deforming of thecovering film (2) leads to an increase in volume of the second chamber(6) and makes it possible for the two substances (A) and (B) to bereceived. The valve film (12) is in this case pressed against thecovering film and thereby prevents the mixture from flowing back intothe first chamber (5) without the device having to be bent in thetransition zone between the two chambers.

Another meaningful application for the device is in the production ofpacks which can be sterilized, for example by gamma rays or heat. As aresult of the pre-forming according to the invention of at least one ofthe films, the substance or substances stored in the sealed device canbe sterilized without any problem by the means mentioned above even if,for example due to the increase in temperature, this causes outgassingof the stored substances, without the device itself being activated orthe transition zones that can be selectively opened and that adjoin thechamber or chambers being opened. This type of use may also be employedin the case of devices which have only one chamber for storing asubstance.

1. A device, comprising a first and a second film, a dispensing zone, afirst chamber, containing a first substance, and a second chamber,containing a second substance, the chambers being connectable to eachother via a transition zone that is selectively openable, at least oneof the films being thermoformed in an area of the chambers, and at leastone of the films having a portion which is deformable in an area of thesecond chamber in such a way that, after activation of the device, withthe transition zone being opened, the first substance is transferablesubstantially completely into the second chamber, with an increase involume of said second chamber, without any appreciable flowing back of amixture into the first chamber occurring; wherein, said deformableportion comprises a portion of said film which is preformed into a firstsurface configuration which provides a first volume for said secondchamber, and is substantially non-reversibly deformable in response topressure applied to an interior of the second chamber, to assume asecond surface configuration which provides ea second volume for saidsecond chamber, which is greater than said first volume.
 2. The deviceaccording to claim 1, wherein at least one of the first and second filmsis concavely-convexly deformed in the area of the second chamber.
 3. Thedevice according to claim 1, wherein at least one of the films has inthe area of the second chamber a form which is obtainable by at leastpartially forming a depression into an initially concavely formedsurface.
 4. The device according to claim 3, wherein the first film iscoextensive with the second film at least in an area of said chambers,and is sealed in a peelable manner at a point of contact with said otherfilm.
 5. The device according to claim 1, wherein the films forming thechambers are pre-formed such that the films are separable from eachother, at least in an edge zone of the second chamber.
 6. The deviceaccording to claim 1, wherein at least one of the films is expandable inthe area of the second chamber.
 7. The device according to claim 1,wherein the second chamber is connectable to the dispensing zone via asecond transition zone that is selectively openable.
 8. The deviceaccording to claim 2, wherein the second chamber is connectable to thedispensing zone via a second transition zone that is selectivelyopenable.
 9. The device according to claim 3, wherein the second chamberis connectable to the dispensing zone via a second transition zone thatis selectively openable.
 10. The device according to claim 5, whereinthe second chamber is connectable to the dispensing zone via a secondtransition zone that is selectively openable.
 11. The device accordingto claim 6, wherein the second chamber is connectable to the dispensingzone via a second transition zone that is selectively openable.
 12. Thedevice according to claim 1, wherein a third chamber is located betweenthe first chamber and the second chamber in the transition zone that isselectively openable.
 13. The device according to claim 2, wherein athird chamber is located between the first chamber and the secondchamber in the transition zone that is selectively openable.
 14. Thedevice according to claim 5, wherein a third chamber is located betweenthe first chamber and the second chamber in the transition zone that isselectively openable.
 15. The device according to claim 6, wherein athird chamber is located between the first chamber and the secondchamber in the transition zone that is selectively openable.
 16. Thedevice according to claim 1, wherein a third film, which protrudes intothe second chamber, is attached to one of the films forming the chambersin the transition zone between the two chambers.
 17. The deviceaccording to claim 2, wherein a third film, which protrudes into thesecond chamber, is attached to one of the films forming the chambers inthe transition zone between the two chambers.
 18. The device accordingto claim 6, wherein a third film, which protrudes into the secondchamber, is attached to one of the films forming the chambers in thetransition zone between the two chambers.
 19. The device according toclaim 7, wherein a third film, which protrudes into the second chamber,is attached to one of the films forming the chambers in the transitionzone between the two chambers.
 20. The device according to claim 1,wherein the chambers have different volumes before activation.
 21. Thedevice according to claim 1, further comprising an applicator.
 22. Thedevice according to claim 1, wherein the applicator is located in thedispensing zone.
 23. The device according to claim 1, wherein the firstsubstance is flowable and the second substance is solid.
 24. The deviceaccording to claim 1, wherein flow barriers are located in thedispensing zone.
 25. The device according to claim 1, wherein thetransition zone that is selectively openable by exposure to ahydrostatic pressure in a range from 3 to 300 N/cm².
 26. A method ofusing the device according to claim 1, said method comprising: storingfirst and second substances in said first and second chamber; mixingsaid first substance into said second substance by applying pressure tosaid first chamber, whereby said first substance flows through saidtransition zone and enters said second chamber, such that the volume ofthe second chamber is substantially non-reversibly enlarged toaccommodate entry of said first substance; and dispensing said first andsecond substances from said second chamber via dispensing zone.
 27. Themethod according to claim 26, wherein the flowable compositions arechosen from: human and veterinary medicaments, wound cleaning agents,dental products, adhesives, impression materials, paints, or foods. 28.A method of making a device, comprising: a) providing a first film, b)partially thermoforming the first film, thereby forming two chambers, c)filling the two chambers with two substances to be mixed in use, d)applying a second film, and e) connecting the second film to the firstfilm substantially in surface-area contact, leaving the chambers freeand forming a transition zone that is selectively openable between thetwo chambers; wherein said second chamber is plastically deformable inresponse to an application of pressure to an interior thereof; and saidplastic deformation causes said second chamber to assume a configurationin which a volume of said second chamber is substantially non-reversiblyincreased relative to said volume before said plastic deformation. 29.The method according to claim 28, wherein the second film is pre-formedin a convex or wave-shaped manner in an area of the second chamberbefore applying the second film.
 30. The method according to claim 28,wherein a third film is connected to the first film in the transitionzone before applying the second film.
 31. A dispensing devicecomprising: a first film, a second film, a dispensing area, a firstchamber containing a first substance, a second chamber containing asecond substance being formed by the films, and an openable transitionarea connecting the chambers, wherein the first film is thermo-formed inan area of the chambers, and at least one of the films is pre-formed orplastically deformable in an area of the second chamber in order tooperatively provide a substantially non-reversibly increased volume forthe second chamber, whereby said second chamber accepts and retainssubstantially all of the first substance transferred from the firstchamber via the transition area.
 32. A device comprising: a base filmand a cover film which are adhered to each other and have first andsecond chambers formed therebetween; a first substance contained in saidfirst chamber, and a second substance contained in said second chamber;a transition zone formed between said dbase film and said cover film,said transition zone extending from said first chamber and said secondchamber being selectively openable to provide a fluid flow connectionbetween said first and second chambers; wherein, said second chamber issubstantially non-reversibly deformable in response to pressure appliedto an interior thereof, whereby its volume is substantiallynon-reversibly increased; said transition zone is openable in responseto pressure applied therein by a deformation of said first chamber whichdecreases its volume and forces substantially all of said firstsubstance to flow through said transition zone and into said secondchamber, whereby said volume of the second chamber is increased bysubstantially irreversible deformation thereof, such that substantiallyall of said first substance remains in said second chamber after saiddeformation of said first chamber.
 33. The device according to claim 32,wherein: said base film has first and second substantially concavedepressions formed therein, which concave depressions form a firstboundary of said first and second chambers; said cover film forms asecond boundary which closes off said first and second chambers; andsaid cover film has a depression pattern formed therein in a vicinityadjacent said second chamber, which depression pattern permits asubstantially non-reversible expansion of said cover film outwardly awayfrom said concave depression of said second chamber.
 34. The deviceaccording to claim 32, wherein: said base film has first and secondsubstantially concave depressions formed therein, which concavedepressions form a first boundary of said first and second chambers;said cover film forms a second boundary which closes off said first andsecond chambers; and said base film is reversibly adhered to said coverfilm in a peripheral area of said second chamber and is plasticallydeformable, whereby said dbase film is detachable from said cover filmin said peripheral area, such that it is expandable substantiallynon-reversibly outwardly away from the cover film and the volume of thesecond chamber is substantially non-reversibly increased, in response toan application of pressure to an interior of aid second chamber.
 35. Thedevice according to claim 33, wherein said depression pattern comprisesa concave depression in said cover film, which concave depressionprojects into said concave depression of the base film which founds thesecond chamber, said concave depression of the said second chamber beingplastically deformable to a configuration in which it extends outwardlyaway from said cover film.
 36. The device according to claim 33, whereinsaid depression pattern comprises a ruffed pattern in said cover film,which ruffed pattern projects into said concave depression of the basefilm which founds the second chamber, said ruffed pattern of the saidsecond chamber being plastically deformable to a configuration in whichit extends outwardly away from said cover film.